Project summary
The establishment of the FORCE Consortium is supported by a 4-year Coordination and Support Action (CSA), funded by the European Union under the Horizon Europe Programme (Grant Agreement no. 101215179). Through this project, we are building a collaborative framework to implement a Pragmatic Clinical Trial Programme led by cancer charities. The FORCE project is supported with an EU contribution of €3.35 million.
The main objective of the FORCE CSA is to provide the Mission Board with an ambitious, yet feasible, program by and for cancer charities, to optimize their contribution to Europe’s Beating Cancer Plan. The Pragmatic Clinical Trial Programme will be elaborated using a bottom-up, coordinated approach, involving all relevant stakeholders – researchers, healthcare professionals, patients, citizens, policymakers, and regulatory authorities – across Member States and Associated Countries.
During the CSA, the FORCE consortium will also propose the foundational pillars for a long-term EU strategic framework to support a European cancer charity network dedicated to organizing, implementing, and monitoring sustainable and impactful support for pragmatic clinical trials in oncology.
The overall objectives of FORCE are to:
Define and deliver a Pragmatic Clinical Trial Programme by cancer charities, with a focus on rare and hard-to-treat cancers;
Implement two transnational calls for proposals to test and refine the feasibility of the proposed program;
Deliver a strategic blueprint to the European Commission to support decision-making and guide future work programs on pragmatic oncology trials funded by charities.
Through the successful achievement of these objectives, the FORCE network will both strengthen collaboration among cancer charities in Europe and mobilize the research community around crucial scientific questions – improving health outcomes for patients through patient-centered, nonprofit-led research.
Work packages
WP1 - Management and coordination of the CSA
General objective
Ensure adequate, effective and efficient coordination and management of the FORCE consortium.
Specific objectives
- To conduct the contract negotiations with the European Commission (EC)
- To draft and implement a Consortium Agreement (CA) defining rules and regulations within the consortium
- To channel communication between the consortium and the EC
- To keep knowledge and information flowing seamlessly and effectively to all pertinent stakeholders
- To ensure that the received funds are correctly distributed between partners and accounted for
- To support the governance structures as specified in the workplan
- To ensure timely fulfilment of deliverables and milestones
- To coordinate and ensure adequate periodic reporting to the EC
- To identify and anticipate potential hurdles and solve issues
WP2 - Deliver a pragmatic clinical trial programme by cancer charities
General objective
Deliver a Pragmatic Clinical Trial Programme (PCTP) for and by cancer charities
Specific objectives
- Define a working definition of what constitutes a pragmatic clinical trial
- Define in which way pragmatism can maximize patient impact
- Determine the types of pragmatic trials to be supported within the programme
- Specify research priorities for the pragmatic clinical trials programme
- Define criteria and ethical rules for selection and implementation of pragmatic clinical trials
- Define the dissemination and communication strategy of the programme
- Deliver a blueprint for pragmatic clinical programme by cancer charities
WP3 - Patient centricity and impact
General objective
To establish a comprehensive, patient-centred engagement strategy that integrates patient perspectives into all phases of the PCTP, ensuring that patient involvement shapes the development, evaluation, and implementation of pragmatic trials.
Specific objectives
- Establish the core group and patient panel
- Collaboratively develop the Patient Engagement Plan, aligned with patient priorities for pragmatic trials
- Develop and implement evaluation of patient engagement in project applications
- Create a mechanism to evaluate and monitor ongoing patient involvement throughout funded trials to
maintain alignment with patient priorities - Evaluate and assess the impact of patient engagement throughout the PCTP
- Engage policymakers into implementing trial outcomes for the benefit of the patients
WP4 - Implementation of the programme
General objective
Guarantee the execution of the initiative by launching two calls implementing the PCTP defined in WP2 and WP5, focusing on ensuring a fair selection process and maximizing the impact on patient outcomes.
Specific objectives
- Manage and coordinate programme activities to ensure timely delivery of outputs
- Facilitate communication and collaboration among consortium partners
- Monitor and evaluate the progress and impact of the calls
WP5 - Governance, organization, sustainability and impact
General objective
Create a governance structure that balances the interests of the different consortia partners and fosters
responsible research and innovation that considers ethical, legal, environmental and social implications of
research and meets societal concerns and needs.
Specific objectives
- To define and evaluate governance rules for the FORCE consortium
- To explore synergies and collaboration with relevant stakeholders and other EU initiatives
- To develop a strategy for the long-term sustainability of the network
- To develop a strategy for reducing inequalities
- To assess the overall impact of the initiative